NDC 68788-7669-01 - montelukast sodium
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68788-7669
- Requested NDC
- 68788-7669-01
- Package NDCs from labels
- 68788-7669-1, 68788-7669-4, 68788-7669-2, 68788-7669-3, 68788-7669-6, 68788-7669-9, 68788-7669-01
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Effective date
- 2026-01-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| montelukast sodium - Preferred Pharmaceuticals, Inc. | Preferred Pharmaceuticals, Inc. | 2026-01-13 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68788-7669-1 | montelukast sodium | 10 in 1 BOTTLE | TABLET, CHEWABLE | 10 | 6 | |
| 68788-7669-2 | montelukast sodium | 20 in 1 BOTTLE | TABLET, CHEWABLE | 20 | 6 | |
| 68788-7669-3 | montelukast sodium | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | 6 | |
| 68788-7669-4 | montelukast sodium | 14 in 1 BOTTLE | TABLET, CHEWABLE | 14 | 6 | |
| 68788-7669-6 | montelukast sodium | 60 in 1 BOTTLE | TABLET, CHEWABLE | 60 | 6 | |
| 68788-7669-9 | montelukast sodium | 90 in 1 BOTTLE | TABLET, CHEWABLE | 90 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7669 | MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20240724_09b0bc9e-3035-45b4-b61b-4aca70848360.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7669-1 | EA - Each | 68788-7669 | d130ce6b-a2ca-45d0-a0a8-17e7747895cc | 1 | 2020-05-08 |
| 68788-7669-2 | EA - Each | 68788-7669 | 7464d2ce-011e-4809-8c93-bd9002fb3eb9 | 1 | 2020-05-08 |
| 68788-7669-3 | EA - Each | 68788-7669 | 7f8181e8-7f69-4d34-a1cb-390fe7cba86b | 1 | 2020-05-08 |
| 68788-7669-4 | EA - Each | 68788-7669 | 6fced204-8cfd-4b4a-9661-6e6b836bf866 | 1 | 2020-05-08 |
| 68788-7669-6 | EA - Each | 68788-7669 | 55367211-9966-44f2-a1cb-1b734d894007 | 1 | 2020-05-08 |
| 68788-7669-9 | EA - Each | 68788-7669 | 53c0e2ee-c978-4e3c-880d-1dd89588f570 | 1 | 2020-05-08 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 1a312a28-8472-4cab-a7dd-d01cd8b2765a | 2026-03-07 | Boxed warning, Warnings, Adverse reactions | ANDA204093 242438 MHM278SD3E |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 25b2049d-3a93-4ac3-8de6-14f5d7ce0315 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | ANDA204093 311759 MHM278SD3E |
| montelukast sodium | MONTELUKAST SODIUM | A-S Medication Solutions | 04b3faff-1ea1-4d2a-aa31-9d6e742e1759 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | ANDA204093 311759 MHM278SD3E |
| Calamine | CALAMINE, PRAMOXINE HCL | Amazon.com Services LLC | aceb0b10-8c90-4a06-8c47-cd1a2b4676a3 | 2026-03-03 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Old East Main Co. | c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d | 2026-03-02 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Chain Drug Marketing Association | 86ff4875-9007-4b7b-8f46-16cbd475d4bb | 2026-02-27 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXINE HCL | Chain Drug Marketing Association | 6c848b98-f01c-40f2-a9aa-2af76cb370c8 | 2026-02-27 | Warnings, Adverse reactions | 1K09F3G675 |
| Levico Prunus | LEVICO PRUNUS | Uriel Pharmacy Inc. | 63db9374-8ee2-48cf-8799-454c95869808 | 2026-02-27 | Warnings | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Family Dollar Stores, Inc | 1a03331e-3676-451c-be22-9a547e8ae6e2 | 2026-02-24 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Perrigo Direct, Inc | 256bd1d4-fd50-408f-9aee-84f218bb4971 | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXIND HCL | Perrigo Direct, Inc | 54a20ec9-ab86-4410-af94-e04393e9d4b3 | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXINE HCL | Meijer, Inc. | 6b369ef2-fd54-4931-a9eb-0fb42834c2ef | 2026-02-19 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Target Corporation | d4ee05c8-ae62-45df-8783-1ed57fa030ec | 2026-02-18 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Topco Associates LLC | 2b32e720-ac71-4d60-bc06-e28a00f8a450 | 2026-02-13 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | CALAMINE, PRAMOXINE HCL | Topco Associates LLC | 15d1ae3f-509c-4e6b-8f0c-cf9265680358 | 2026-02-13 | Warnings, Adverse reactions | 1K09F3G675 |
| Calamine | FERRIC OXIDE RED | Major Pharmaceuticals | c25be68d-834a-4959-8d47-01ec789406ba | 2026-02-04 | Warnings, Adverse reactions | 1K09F3G675 |
| Aquavit 1 | AQUAVIT 1 | Uriel Pharmacy Inc. | 2354fcfc-05a2-444a-ace4-b3df61413157 | 2026-02-02 | Warnings | 1K09F3G675 |
| Calamine | CALAMINE | AMERISOURCE BERGEN | 90d9d908-57ea-4062-ade0-8a4888939c91 | 2026-01-29 | Warnings, Adverse reactions | 1K09F3G675 |
| montelukast sodium | MONTELUKAST SODIUM | Preferred Pharmaceuticals, Inc. | 09b0bc9e-3035-45b4-b61b-4aca70848360 | 2026-01-13 | Boxed warning, Warnings, Adverse reactions | ANDA204093 68788-7669-4 68788-7669-2 68788-7669-9 68788-7669-1 68788-7669-6 68788-7669-3 68788-7669 68788766901 242438 f9ab7e9f-ce5e-4c52-919e-66602d0c719e 09b0bc9e-3035-45b4-b61b-4aca70848360 MHM278SD3E |
| First Chakra (Root) 7301 | FIRST CHAKRA (ROOT) | Professional Complementary Health Formulas | 61eb1bbe-6675-4369-b852-18975e6b08c7 | 2026-01-08 | Warnings | 1K09F3G675 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.